NCT06237257进行中（未招募）2 期
A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
Shanghai Shengdi Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年3月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Type, incidence and grade of drug-related adverse events of grade 3 and above
研究概览
简要总结
The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.
The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix；
- •Has locally advanced cervical cancer；
- •At least one measurable lesion ( RECIST version 1.1)；
- •Investigator assess it is suitable for concurrent chemoradiotherapy;
- •Has provided a tissue sample from tumor lesion;
- •Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •BMI≥18.5kg/m2；
- •Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug，Female participants' HCG must be negative within 3 days prior to enrollment and must be non-lactating.
排除标准
- •Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix；
- •The presence of distant metastatic disease was confirmed by pathology or imaging;
- •has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy;
- •In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study.
研究组 & 干预措施
SHR-1316 plus concurrent chemoradiotherapy
Experimental
干预措施: SHR-1316 (Biological)
SHR-1316 plus concurrent chemoradiotherapy
Experimental
干预措施: Cisplatin Injection/Carboplatin Injection (Drug)
SHR-1316 plus concurrent chemoradiotherapy
Experimental
干预措施: External Beam Radiotherapy (EBRT)/Brachytherapy (Radiation)
SHR-1316 plus concurrent chemoradiotherapy
Experimental
干预措施: Paclitaxel Injection (Drug)
结局指标
主要结局
Type, incidence and grade of drug-related adverse events of grade 3 and above
时间窗: Up to approximately 24 months
次要结局
- Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug(Up to approximately 30 months)
- Objective Response Rate(ORR)(Up to approximately 60 months)
- Duration of response (DoR)(Up to approximately 60 months)
- 12-week Complete Response(Up to approximately 4 months)
- PK traits of SHR-1316: Cmax(Up to approximately 24 months)
- PK traits of SHR-1316: CL(Up to approximately 24 months)
- PK traits of SHR-1316: Vss(Up to approximately 24 months)
- Progression free survival (PFS)(Up to approximately 60 months)
- PK traits of SHR-1316: AUC0-t(Up to approximately 24 months)
- Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs(Up to approximately 30 months)
- Overall Survival (OS)(Up to approximately 60 months)
- 2-year Progression free survival(Up to approximately 24 months)
- 3-year Overall Survival(Up to approximately 36 months)
- PK traits of SHR-1316: Tmax(Up to approximately 24 months)
- PK traits of SHR-1316: AUC0-∞(Up to approximately 24 months)
- PK traits of SHR-1316: t1/2(Up to approximately 24 months)
- Serum concentration of SHR-1316 at each planned blood collection time point(Up to approximately 24 months)
研究者
研究点 (1)
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